The Predictive Value of the Sperm Chromatin Dispersion Test, Halosperm®, Before and After Sperm Preparation for Clinical Pregnancy in Cases of Unexplained Infertility Treated With Intra-uterine Insemination (First Cycle) and Ovulation Induction With Clomiphene Citrate.
NCT ID: NCT02235103
Last Updated: 2016-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
21 participants
OBSERVATIONAL
2014-04-30
2016-03-31
Brief Summary
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We are planning a study to examine the incidence of DNA fragmentation in the sperm of couples with previously unexplained infertility. In a first treatment cycle with intra-uterine insemination the percentage of DNA fragmentation in sperm will be measured. Afterwards the results of the patients who are pregnant will be compared with those of the not pregnant ones. We expect to find differences between both groups.
100 patients will be included in the study.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Clinical Pregnancy
Patients who are clinically pregnant after first treatment cycle with intra-uterine insemination.
Sperm Chromatin Dispersion Test
No Clinical Pregnancy
Patients who are not clinically pregnant after first treatment cycle with intra-uterine insemination.
Sperm Chromatin Dispersion Test
Interventions
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Sperm Chromatin Dispersion Test
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient agrees to have a first treatment cycle with intra-uterine insemination and ovulation-induction with clomiphene citrate.
18 Years
40 Years
ALL
No
Sponsors
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University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Frank Vandekerckhove, MD
Role: PRINCIPAL_INVESTIGATOR
Fertility Centre, University Hospital Ghent
Locations
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Fertility Centre of the University Hospital
Ghent, East Flanders, Belgium
Countries
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Other Identifiers
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B670201316616
Identifier Type: -
Identifier Source: org_study_id
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